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Comment: PSETCD in TX and LVLDESC in RELREF corrected

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Dataset wrap
Nametx
Rowcaps
Rows 1-14:Show trial set, SetSTM, with trial set parameters and trial set values that comprise the test conditions for all data for the species Salmonella Typhimurium. 
Rows 15, 24, 33, 42:Show that SetA, SetF, SetG, and SetR each have a parent set code of SetSTM.  As a child set of SetSTM, each of these sets inherit the test conditions of SetSTM.
Rows 16-23-22:Show trial set parameters and trial set values that comprise the test conditions for the set SetA. SetA is the data for the vehicle control (i.e., Strain of TA98, vehicle control with concentration value of 0). SetA is associated with the first row, labeled "SetA", in the report table for example study 8325064.
Rows 2325-3032:Show trial set parameters and trial set values that comprise the test conditions for the set SetF. SetF is the data for the strain of TA98 with a concentration value of 500 µg/plate. SetF is associated with the sixth row, labeled "SetF", in the report table for example study 8325064.
Rows 3133-3841:Show trial set parameters and trial set values that comprise the test conditions for the set SetG. SetG is the data for the strain of TA98 with a concentration value of 1600 µg/plate. SetG is associated with the seventh row, labeled "SetG", in the report table for example study 8325064.
Rows 3942-4650:Show trial set parameters and trial set values that comprise the test conditions for the set SetR. SetR is the data for the strain of TA100, positive control with a concentration value of 2 µg/plate. SetR is associated with the eighteenth row, labeled "SetR", in the report table for example study 8325064.
Row 10:

Shows a value for SPTOBID=CIG01a.  SPTOBID is Sponsor-Defined Tobacco Product ID that is used to uniquely identify the tobacco product. The value of SPTOBID, in this case CIG01a, matches the value for SPTOBID in all the TOPARMCD-TOVAL pairs in the Tobacco Product Identifiers and Descriptors (TO) dataset example in Section 3.1.2 Product Design Parameters and Conformance Testing Example 1. The TOPARMCD-TOVAL pairs identify this unique product, CIG01a.

The TO domain is described in the Section 2.8.8.1 Tobacco Product Identifiers and Descriptors (TO).

Row 13:

Shows a value for SPDEVID.  SPDEVID is the Sponsor defined device identifier that is used to uniquely identify the device in the Unique Device Identification (DI) dataset. The value of SPDEVID, in this case PUFFMASTER3K, matches the value of SPDEVID in all the DIPARMCD-DIVAL pairs that identify this unique device in the DI dataset. This is shown in the di.xpt in SDTM Example.Product HPHC ENDS Testing.

The DI domain is described in the Section 2.8.9.7 Device Identifiers (DI).

Row 14:

Shows a value for DUREFID. DUREFID serves as a link to the Device-In Use Properties (DU) domain, where a matching value of DUREFID indicates parameters of the smoking regimen performed by the smoking machine, as in the du.xpt in SDTM Example.Product HPHC ENDS Testing.

The DU domain is described in the Section 2.8.9.8 Device-In-Use (DU).

Dataset2

 

RowSTUDYIDGNTXAIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
18325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM

1

SPECIESSpeciesSALMONELLA TYPHIMURIUM
28325064AmesTXSetSTM

SALMONELLA TYPHIMURIUM

2TRTDMINTreatment Duration Minimum71.5
38325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM3TRTDTRGTreatment Duration Target72
48325064AmesTXSetSTMSALMONELLA TYPHIMURIUM4TRTDMAXTreatment Duration Maximum72.5
58325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM

5TRTDUTreatment Duration UnitHOURS
68325064AmesTXSetSTMSALMONELLA TYPHIMURIUM6INCBTMPIncubation Temperature37
78325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM7INCBTMPUIncubation Temperature UnitC
88325064AmesTXSetSTM

SALMONELLA TYPHIMURIUM

8HUMIDAtmospheric Relative Humidity Percent50
98325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM9ATMCO2Atmospheric CO2 Percent5
108325064AmesTXSetSTMSALMONELLA TYPHIMURIUM10SPTOBID

Sponsor defined tobacco identifier

CIG01a
118325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM

11EXPTYP

Exposure Type

Submerged
128325064AmesTXSetSTMSALMONELLA TYPHIMURIUM12SAMTYP

Sample Type

Total Particulate Matter in PBS
138325064AmesTXSetSTM

SALMONELLA TYPHIMURIUM

13SPDEVIDSponsor defined device identifierPUFFMASTER3K
148325064AmesTXSetSTMSALMONELLA TYPHIMURIUM14DUREFIDSmoke RegimenNON-INTENSE REGIMEN
158325064AmesTXSetAA-TA98-C015STRAINStrain/SubstrainPSETCDParent Set CodeSetSTMTA98
168325064AmesTXSetAA-TA98-C015STRAINStrain/SubstrainTA98
178325064AmesTX

SetA

A-TA98-C01616METACTMetabolic ActivationNOT APPLICABLE
17188325064AmesTX

SetA

A-TA98-C017METACTFLY/N presence of metabolic activationN
18198325064AmesTXSetAA-TA98-C018INTRVN

Name of the intervention article

TA1
19208325064AmesTXSetAA-TA98-C019ITVTYPE

Type of intervention article

Vehicle Control
20218325064AmesTXSetAA-TA98-C020ITVCONCConcentration of intervention article0
21228325064AmesTXSetAA-TA98-C021ITVCONCUConcentration Unitug/plate
22238325064AmesTXSetAA-TA98-C022TRTVTreatment VehicleDMSO
248325064AmesTXSetFF-TA98-C500
PSETCDParent Set CodeSetSTM
25238325064AmesTXSetFF-TA98-C50023STRAINStrain/SubstrainTA98
24268325064AmesTXSetFF-TA98-C50024METACTMetabolic ActivationNOT APPLICABLE
25278325064AmesTXSetFF-TA98-C50025METACTFLY/N presence of metabolic activationN
26288325064AmesTXSetFF-TA98-C50026INTRVN

Name of the intervention article

TA1
27298325064AmesTXSetFF-TA98-C50027ITVTYPE

Type of intervention article

Product
28308325064AmesTXSetFF-TA98-C50028ITVCONCConcentration of intervention article500
29318325064AmesTXSetFF-TA98-C50029ITVCONCUConcentration Unitug/plate
30328325064AmesTXSetFF-TA98-C50030TRTVTreatment VehicleDMSOTreatment VehicleDMSO
338325064AmesTXSetGG-TA98-C160031PSETCDParent Set CodeSetSTM
34318325064AmesTXSetGG-TA98-C160031STRAINStrain/SubstrainTA98
32358325064AmesTXSetGG-TA98-C160032METACTMetabolic ActivationNOT APPLICABLE
33368325064AmesTXSetGG-TA98-C160033METACTFLY/N presence of metabolic activationN
34378325064AmesTXSetGG-TA98-C160034INTRVN

Name of the intervention article

TA1
35388325064AmesTXSetGG-TA98-C160035ITVTYPE

Type of intervention article

Product
36398325064AmesTXSetGG-TA98-C160036ITVCONCConcentration of intervention article1600
37408325064AmesTXSetGG-TA98-C160037ITVCONCUConcentration Unitug/plate
38418325064AmesTXSetGG-TA98-C160038TRTVTreatment VehicleDMSO
428325064AmesTX

SetR

R-TA100-C239PSETCDParent Set CodeSetSTM
438325064AmesTX

SetR

R-TA100-C239STRAINStrain/SubstrainTA100
40448325064AmesTX

SetR

R-TA100-C240METACTMetabolic ActivationNOT APPLICABLE
41458325064AmesTX

SetR

R-TA100-C241METACTFLY/N presence of metabolic activationN
42468325064AmesTX

SetR

R-TA100-C242INTRVN

name of the intervention article

NaN3
43478325064AmesTX

SetR

R-TA100-C243ITVTYPE

type of intervention article

Positive Control
44488325064AmesTX

SetR

R-TA100-C244ITVCONCConcentration of intervention article2
45498325064AmesTX

SetR

R-TA100-C245ITVCONCUConcentration Unitug/plate
46508325064AmesTX

SetR

R-TA100-C246TRTVTreatment VehicleDMSO

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Dataset wrap
Namerelref
Rowcaps
Row 1:

Shows the value of REFID=STM, This REFID refers to the trial set with a SETCD of 'SetSTM', as defined in the trial set dataset, tx.xpt.   LEVEL=1 and LVLDESC='TRIAL SET' indicates this identifier relates to the entire trial set.

Rows 1, 2, 8, 12, 16:

Show that the trial set, SetSTM, is the parent of set codes SetA, SetF, SetG, and SetR.

Row 2:Shows the value of REFID=A, This REFID refers to the trial set with a SETCD of 'SetA', as defined in the trial set dataset, tx.xpt.  LEVEL=2 and LVLDESC='TRIAL SET' indicates this identifier relates to the entire trial set.
Rows 3-7:Show the values of five observational units 1_1 through 1_5 that are within the parent experimental unit, REFID=A
Row 8: Shows the value of REFID=F, This REFID refers to the trial set with a SETCD of 'SetF', as defined in the trial set dataset, tx.xpt.  LEVEL=2 and LVLDESC='TRIAL SET' indicates this identifier relates to the entire trial set.
Rows 9-11:Show the values of three observational units 6_1 through 6_3 that are within the parent experimental unit, REFID=F
Row 12:Shows the value of REFID=G, This REFID refers to the trial set with a SETCD of 'SetG', as defined in the trial set dataset, tx.xpt.  LEVEL=2 and LVLDESC='TRIAL SET' indicates this identifier relates to the entire trial set.
Rows 13-15:Show the values of three observational units 7_1 through 7_3 that are within the parent experimental unit, REFID=G
Row 16:Shows the value of REFID=R. This REFID refers to the trial set with a SETCD of 'SetG', as defined in the trial set dataset, tx.xpt.  LEVEL=2 and LVLDESC='TRIAL SET' indicates this identifier relates to the entire trial set.
Rows 17-19:Show the values of three observational units 18_1 through 18_3 that are within the parent experimental unit, REFID=R
Dataset2
tableidrelref.xpt

Row

STUDYID

GNTXAID

SETCD

REFID

PARENT

LEVEL

LVLDESC

1

8325064

Ames

SetSTM

STM


1

TRIAL SET

2

8325064

Ames

SetA

A

STM

2

EXPERIMENTAL UNIT/TRIAL SET

3

8325064

Ames

SetA

1_1

A

3

OBSERVATIONAL UNIT

4

8325064

Ames

SetA

1_2

A

3

OBSERVATIONAL UNIT

5

8325064

Ames

SetA

1_3

A

3

OBSERVATIONAL UNIT

6

8325064

Ames

SetA

1_4

A

3

OBSERVATIONAL UNIT

7

8325064

Ames

SetA

1_5

A

3

OBSERVATIONAL UNIT

8

8325064

Ames

SetF

F

STM

2

EXPERIMENTAL UNIT/TRIAL SET

9

8325064

Ames

SetF6_1F

3

OBSERVATIONAL UNIT

10

8325064

Ames

SetF6_2F

3

OBSERVATIONAL UNIT

11

8325064

Ames

SetF

6_3F

3

OBSERVATIONAL UNIT

12

8325064

Ames

SetG

G

STM

2

EXPERIMENTAL UNIT/TRIAL SET

13

8325064

Ames

SetG7_1G

3

OBSERVATIONAL UNIT

14

8325064

Ames

SetG

7_2G

3

OBSERVATIONAL UNIT

15

8325064

Ames

SetG7_3G

3

OBSERVATIONAL UNIT

16

8325064

Ames

SetG

R

STM

2

EXPERIMENTAL UNIT/TRIAL SET

17

8325064

Ames

SetR18_1R

3

OBSERVATIONAL UNIT

18

8325064

Ames

SetR18_2R

3

OBSERVATIONAL UNIT

19

8325064

Ames

SetR18_3R

3

OBSERVATIONAL UNIT

...